Title:
DRONEDARONE HYDROCHLORIDE PHARMACEUTICAL COMPOSITION, AND PREPARATION METHOD THEREFOR AND USE THEREOF
Document Type and Number:
WIPO Patent Application WO/2022/083636
Kind Code:
A1
Abstract:
Provided are a dronedarone hydrochloride clathrate, a preparation method therefor and the use thereof. The dronedarone hydrochloride clathrate comprises dronedarone hydrochloride and cyclodextrin, wherein the cyclodextrin does not comprise β-cyclodextrin without a substituent. The dronedarone hydrochloride clathrate has a good stability in solution and a greatly improved solubility in water. The solubility of the dronedarone hydrochloride clathrate is improved by approximately 90 times as compared to that of dronedarone hydrochloride, so that the dronedarone hydrochloride clathrate has a high bioavailability, and is suitable for industrial production.
Inventors:
GUO ZHEN (CN)
QIN WEI (CN)
GUAN AI (CN)
CHEN LI (CN)
WANG TINGTING (CN)
YING SHUHUAN (CN)
QIN WEI (CN)
GUAN AI (CN)
CHEN LI (CN)
WANG TINGTING (CN)
YING SHUHUAN (CN)
Application Number:
PCT/CN2021/124961
Publication Date:
April 28, 2022
Filing Date:
October 20, 2021
Export Citation:
Assignee:
SHANGHAI BOCIMED PHARMACEUTICAL CO LTD (CN)
SHANGHAI BOCIMED PHARMACEUTICAL RES CO LTD (CN)
SHANGHAI BOCIMED PHARMACEUTICAL RES CO LTD (CN)
International Classes:
A61K9/20; A61K47/69; A61K31/343; A61P9/06
Foreign References:
| CN103054820A | 2013-04-24 | |||
| CN103169691A | 2013-06-26 | |||
| CN1479610A | 2004-03-03 |
Other References:
MARCOLINO ANA ISA PEDROSO, MACEDO LETÍCIA BUENO, NOGUEIRA-LIBRELOTTO DANIELE RUBERT, FERNANDES JOANA RODRIGUES, BENDER CAROLINE RA: "Preparation, characterization and in vitro cytotoxicity study of dronedarone hydrochloride inclusion complexes", MATERIALS SCIENCE AND ENGINEERING C, ELSEVIER SCIENCE S.A., CH, vol. 100, 1 July 2019 (2019-07-01), CH , pages 48 - 61, XP055922931, ISSN: 0928-4931, DOI: 10.1016/j.msec.2019.02.097
MARCOLINO ANA ISA PEDROSO, MACEDO LETÍCIA BUENO, NOGUEIRA-LIBRELOTTO DANIELE RUBERT, VINARDELL MARÍA PILAR, ROLIM CLARICE MADALENA: "Comparative evaluation of the hepatotoxicity, phototoxicity and photosensitizing potential of dronedarone hydrochloride and its cyclodextrin-based inclusion complexes", PHOTOCHEMICAL & PHOTOBIOLOGICAL SCIENCES, ROYAL SOCIETY OF CHEMISTRY , CAMBRIDGE, GB, vol. 18, no. 6, 12 June 2019 (2019-06-12), GB , pages 1565 - 1575, XP055922935, ISSN: 1474-905X, DOI: 10.1039/C8PP00559A
MARCOLINO ANA ISA P., SCHEEREN LAÍS E., NOGUEIRA-LIBRELOTTO DANIELE R., FERNANDES JOANA R., ADAMS ANDRÉA I. H., DE CARVALHO LEANDR: "Establishment of a stability indicating HPLC method for dronedarone hydrochloride in tablets and in cyclodextrin inclusion complexes: application to degradation kinetic studies.", CHEMICAL PAPERS, vol. 73, no. 4, 1 April 2019 (2019-04-01), Cham , pages 871 - 881, XP009535841, ISSN: 2585-7290, DOI: 10.1007/s11696-018-0643-z
SUDHA N., SAMEENA Y., CHANDRASEKARAN S., ENOCH ISRAEL V. M. V., PREMNATH D.: "Alteration of the Binding Strength of Dronedarone with Bovine Serum Albumin by β-Cyclodextrin: A Spectroscopic Study", SPECTROSCOPY LETTERS, vol. 48, no. 2, 7 February 2015 (2015-02-07), US , pages 112 - 119, XP009535842, ISSN: 0038-7010, DOI: 10.1080/00387010.2013.858052
MARCOLINO ANA ISA PEDROSO, MACEDO LETÍCIA BUENO, NOGUEIRA-LIBRELOTTO DANIELE RUBERT, VINARDELL MARÍA PILAR, ROLIM CLARICE MADALENA: "Comparative evaluation of the hepatotoxicity, phototoxicity and photosensitizing potential of dronedarone hydrochloride and its cyclodextrin-based inclusion complexes", PHOTOCHEMICAL & PHOTOBIOLOGICAL SCIENCES, ROYAL SOCIETY OF CHEMISTRY , CAMBRIDGE, GB, vol. 18, no. 6, 12 June 2019 (2019-06-12), GB , pages 1565 - 1575, XP055922935, ISSN: 1474-905X, DOI: 10.1039/C8PP00559A
MARCOLINO ANA ISA P., SCHEEREN LAÍS E., NOGUEIRA-LIBRELOTTO DANIELE R., FERNANDES JOANA R., ADAMS ANDRÉA I. H., DE CARVALHO LEANDR: "Establishment of a stability indicating HPLC method for dronedarone hydrochloride in tablets and in cyclodextrin inclusion complexes: application to degradation kinetic studies.", CHEMICAL PAPERS, vol. 73, no. 4, 1 April 2019 (2019-04-01), Cham , pages 871 - 881, XP009535841, ISSN: 2585-7290, DOI: 10.1007/s11696-018-0643-z
SUDHA N., SAMEENA Y., CHANDRASEKARAN S., ENOCH ISRAEL V. M. V., PREMNATH D.: "Alteration of the Binding Strength of Dronedarone with Bovine Serum Albumin by β-Cyclodextrin: A Spectroscopic Study", SPECTROSCOPY LETTERS, vol. 48, no. 2, 7 February 2015 (2015-02-07), US , pages 112 - 119, XP009535842, ISSN: 0038-7010, DOI: 10.1080/00387010.2013.858052
Attorney, Agent or Firm:
BEIJING ORIGINTELLIGENCE IP LAW FIRM (CN)
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